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Celgene keys in on ASH for critical look at its drugs of the future

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Dive Brief:

  • Third-quarter sales growth caused Celgene to boost its 2018 guidance up $200 million to $15.2 billion, but investors and the company itself remained more focused on its experimental drug candidates on a Thursday morning earnings call.
  • The New Jersey-based biotech touted its leading drug prospects — dubbed «the big five» by the company’s chief executive — and also talked up the American Society of Hematology’s annual meeting set for Dec. 1-4 as a key look at its pipeline progress.
  • Celgene’s president of hematology and oncology Nadim Ahmed said on the Oct. 25 earnings call that ASH «will highlight the significant advancement of our pipeline» and include data from six studies of five drugs.

Dive Insight:

Investor concern over Celgene’s future has become a recurrent theme and, mimicking last quarter’s earning call, executives pointed to five candidates as the company’s foundation for future growth.

These five therapies are ozanimod for multiple sclerosis, fedratinib for myelofibrosis, luspatercept for blood disorders, bb2121 for multiple myeloma and liso-cel for blood cancers.

On the Oct. 25 earnings call, CEO Mark Alles remarked these drugs would «largely offset» a complete loss in revenue from Revlimid (lenalidomide).

Revlimid was one of the world’s best-selling drugs in 2017, posting $8.2 billion in global sales last year. Those sales grew 18% in the third quarter compared to a year ago to $2.4 billion, accounting for slightly more than 60% of Celgene’s total third quarter revenue.

The overhanging concern for the biotech is what will happen in 2022, when Revlimid will face generic competition from Teva Pharmaceutical through a settlement deal the companies reached. Broader generic competition won’t happen until 2026, Celgene’s leader said.

The impending patent cliff has made it vital for the biotech to find additional revenue-driving drugs sooner rather than later, and Celgene executives said on the call they believe all five will launch within roughly two years.

«We see a nice replacement of those revenues from the big five,» Alles said. «That’s why the end of 2020 is such an important window for these five assets to be approved for their first indications.»

Additionally, several of these candidates will be featured at ASH in a few weeks, and investors could get a better understanding of what to expect when abstracts for the conference are released.

For December’s ASH conference, Celgene execs said the following clinical trials will roll results out:

  • Luspatercept’s Phase 3 trial in low-to-intermediate risk myelodysplastic syndromes
  • Luspatercept’s Phase 3 trial in beta-thalassemia
  • Liso-cel’s Phase 1/2 data in relapsed or refractory chronic lymphocytic leukemia
  • bb21217’s Phase 1 data in relapsed or refractory multiple myeloma
  • JCARH125’s Phase 1/2 data in relapsed or refractory multiple myeloma
  • Revlimid’s Phase 3 data in relapsed or refractory indolent lymphoma in combination with Rituxan (rituximab)

The two Phase 3 luspatercept studies both had positive top-line readouts over the summer.

And while ozanimod will not be featured at ASH, Celgene also stated that its TRUE NORTH Phase 3 study in ulcerative colitis remains set to complete enrollment mid-2019.

Overall, third quarter financials were «solid, but not spectacular,» as Cowen & Co.’s Phil Nadeau wrote in an investors’ note.

Revenue was up 18% compared to the third quarter of 2017 at $3.9 billion, and sales growth of psoriasis drug Otezla (apremilast) led the way with a year-over-year increase of 40%. Half of the $200 million increase to 2018 guidance came from growing Otezla sales.

Despite financials that analysts generally deemed positive, Celgene’s stock see-sawed Thursday morning, opening on the market up more than 1% before going as much as 3% down compared to Wednesday’s close.

Dive Brief:

  • Third-quarter sales growth caused Celgene to boost its 2018 guidance up $200 million to $15.2 billion, but investors and the company itself remained more focused on its experimental drug candidates on a Thursday morning earnings call.
  • The New Jersey-based biotech touted its leading drug prospects — dubbed «the big five» by the company’s chief executive — and also talked up the American Society of Hematology’s annual meeting set for Dec. 1-4 as a key look at its pipeline progress.
  • Celgene’s president of hematology and oncology Nadim Ahmed said on the Oct. 25 earnings call that ASH «will highlight the significant advancement of our pipeline» and include data from six studies of five drugs.

Dive Insight:

Investor concern over Celgene’s future has become a recurrent theme and, mimicking last quarter’s earning call, executives pointed to five candidates as the company’s foundation for future growth.

These five therapies are ozanimod for multiple sclerosis, fedratinib for myelofibrosis, luspatercept for blood disorders, bb2121 for multiple myeloma and liso-cel for blood cancers.

On the Oct. 25 earnings call, CEO Mark Alles remarked these drugs would «largely offset» a complete loss in revenue from Revlimid (lenalidomide).

Revlimid was one of the world’s best-selling drugs in 2017, posting $8.2 billion in global sales last year. Those sales grew 18% in the third quarter compared to a year ago to $2.4 billion, accounting for slightly more than 60% of Celgene’s total third quarter revenue.

The overhanging concern for the biotech is what will happen in 2022, when Revlimid will face generic competition from Teva Pharmaceutical through a settlement deal the companies reached. Broader generic competition won’t happen until 2026, Celgene’s leader said.

The impending patent cliff has made it vital for the biotech to find additional revenue-driving drugs sooner rather than later, and Celgene executives said on the call they believe all five will launch within roughly two years.

«We see a nice replacement of those revenues from the big five,» Alles said. «That’s why the end of 2020 is such an important window for these five assets to be approved for their first indications.»

Additionally, several of these candidates will be featured at ASH in a few weeks, and investors could get a better understanding of what to expect when abstracts for the conference are released.

For December’s ASH conference, Celgene execs said the following clinical trials will roll results out:

  • Luspatercept’s Phase 3 trial in low-to-intermediate risk myelodysplastic syndromes
  • Luspatercept’s Phase 3 trial in beta-thalassemia
  • Liso-cel’s Phase 1/2 data in relapsed or refractory chronic lymphocytic leukemia
  • bb21217’s Phase 1 data in relapsed or refractory multiple myeloma
  • JCARH125’s Phase 1/2 data in relapsed or refractory multiple myeloma
  • Revlimid’s Phase 3 data in relapsed or refractory indolent lymphoma in combination with Rituxan (rituximab)

The two Phase 3 luspatercept studies both had positive top-line readouts over the summer.

And while ozanimod will not be featured at ASH, Celgene also stated that its TRUE NORTH Phase 3 study in ulcerative colitis remains set to complete enrollment mid-2019.

Overall, third quarter financials were «solid, but not spectacular,» as Cowen & Co.’s Phil Nadeau wrote in an investors’ note.

Revenue was up 18% compared to the third quarter of 2017 at $3.9 billion, and sales growth of psoriasis drug Otezla (apremilast) led the way with a year-over-year increase of 40%. Half of the $200 million increase to 2018 guidance came from growing Otezla sales.

Despite financials that analysts generally deemed positive, Celgene’s stock see-sawed Thursday morning, opening on the market up more than 1% before going as much as 3% down compared to Wednesday’s close.

 

Πηγή

Thanasis Chalikias Προβολή όλων

A Product Manager with expertise in pharma marketing and sales operations

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